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Comparable Outcomes of Patients Eligible versus Ineligible for SWOG Leukemia Studies

Abby Statler, Megan Othus, Harry P. Erba, Thomas R. Chauncey, Jerald P. Radich, Steven Coutre, Anjali Advani, Sucha Nand, Farhad Ravandi, Sudipto Mukherjee and Mikkael A. Sekeres

Key points

  • The majority of ineligible patients had missing documentation or lab values outside of the SWOG leukemia protocols' defined timeframes.

  • Safety and efficacy outcomes between ineligible and eligible patients enrolled on SWOG leukemia studies were comparable.

Abstract

Patients may be deemed ineligible for a clinical trial for reasons that do not directly impact efficacy or safety. We identified and categorized reasons for ineligibility and compared outcomes of ineligible with eligible patients treated on SWOG Leukemia Committee protocols. Patients enrolled in SWOG phase II, II/III, or III protocols open since 2005 were analyzed for eligibility status, reasons for ineligibility, baseline characteristics, Eastern Cooperative Oncology Group (ECOG) performance status (PS), serious adverse events (SAEs), and outcomes, including complete remission (CR) status and overall survival (OS). A total of 2,361 patients were enrolled in the 13 included studies. Of these, 247 (10%) were deemed ineligible: 78 were excluded from analyses while 169 were included. Of the 78 patients excluded from analyses, the majority (73%; 57/78) did not have the disease of interest. Of the 169 included in analyses 60% (101/169) were excluded due to missing baseline documentation. Baseline characteristics comparing ineligible to eligible patients were similar, with the exception of ECOG PS, for S0325 (p=0.02) and S0530 (p=0.002). In multivariable analyses, neither the proportion of patients with ECOG PS 2 or higher (p=0.12) nor the rate of grade 5 SAEs: (p=0.62) differed between groups. There was no difference in survival between the eligible and ineligible patients (p=0.25), and CR rates were similar, with the exception of S0325 (p<0.001) and S0703 (p=0.004). The findings of this study suggest that non-essential eligibility criteria, specifically those associated with missing documentation, can be less restrictive, thus expanding patient enrollment and avoiding protocol deviations. The clinical trials included in this study were registered at www.clincialtrials.gov as #NCT00085709 (S0106), #NCT00066794 (S0301), #NCT00070499 (S0325), #NCT00109837 (S0333), #NCT00093418 (S0432), #NCT00492856 (S0521), #NCT00337168 (S0530), #NCT00352365 (S0605), #NCT00658814 (S0703), #NCT00792948 (S0805), #NCT00945815 (S0910), #NCT00840177 (S0919), and #NCT01522976 (S1117).

  • Submitted January 12, 2018.
  • Accepted March 30, 2018.